AngioDynamics enrolls first patient in NanoKnife DIRECT clinical study
AngioDynamics announced enrollment of the first patient in its NanoKnife Irreversible Electroporation "Data IRE Cancer Treatment" clinical study. The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. The first patient enrollment closely follows the United States Food and Drug Administration's April 1, 2019 approval of AngioDynamics' investigational device exemption application. AngioDynamics' DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, which allows participating sites to obtain coverage for procedures performed in addition to any related routine costs. The DIRECT Study comprises a Randomized Controlled Trial at up to 15 sites, as well as a Real-World Evidence, next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival. As part of the DIRECT Study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants.